- Edwards Lifesciences (Irvine, CA)
- …Surgical Structural Heart), and other Business Unit or Corporate functions such as Regulatory Affairs, Compliance , and others. + Reviewing and advising on a ... as needed.** **How you'll make an impact:** The Manager, Regulatory Counsel reports to the Senior Director, Regulatory...will be responsible for timely review and analysis of clinical contracts, review and approval of advertising and promotion… more
- Mount Sinai Health System (New York, NY)
- …2 years managing investigator-initiated trials preferred. + Proven track record in regulatory compliance , project management, and team leadership. + Progressive ... Prioritize resources and allocate tasks to ensure timelines and objectives are met. ** Regulatory Compliance and Quality Assurance:** + Ensure all trials adhere… more
- Mohawk Valley Health System (Utica, NY)
- …initiatives and support of patient advocate processes. + Oversee enterprise-wide compliance with ongoing regulatory and accreditation readiness sustaining ... of the response needed. + Collaborates with many other departments to ensure compliance with regulatory information. + Ongoing relationships with DOH, DNV,… more
- Surgery Care Affiliates (AL)
- …key performance indicators (KPIs) relevant to quality, patient safety, accreditation and regulatory compliance and impact on SCA vitals, goals, strategic plan, ... including: + Collaborates with other departments such as legal, regulatory compliance , human resources, etc. to ensure...+ Develop, update, and maintain patient safety, quality, and/or clinical compliance programs, play books, tool kits,… more
- Mount Sinai Health System (New York, NY)
- …teams using the principles of high reliability. 6. Reviews unit progress, changes and compliance with quality and safety metrics with clinical nurses and other ... collaboratively with physician dyads and the healthcare team to promote patient care and regulatory standards. 4. Assists in the compliance of a nursing unit… more
- Stryker (Redmond, WA)
- …+ Evaluate product classification and jurisdiction, and determine appropriate regulatory pathways and compliance requirements (local, national, international) ... and claims, while maintaining current product registrations + Assess proposed pre- clinical , clinical , and manufacturing changesfor regulatory impact… more
- Edwards Lifesciences (Irvine, CA)
- …procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance , consistency, and accuracy + Provide ... content product and process changes, and product documentation to assure regulatory requirements compliance , consistency, and accuracy **What you'll need… more
- Ascendis Pharma (Princeton, NJ)
- …medical, payor, corporate, and other non-promotional materials to assess for regulatory compliance with the applicable regulations, guidance documents, and ... working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs, Advertising and Promotion will be an internal expert on US FDA… more
- University of Colorado (Aurora, CO)
- …the Food and Drug Administration (FDA), study protocols, department, hospital / clinical standard operating procedures and other regulatory guidelines + ... Clinical Sciences Professional (Open Rank)- Pediatric Endocrinology Research...grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance , sponsor communication and post and… more
- Tenet Healthcare (Detroit, MI)
- …well as knowledge of statistical or spreadsheet software tools Job : Non- Clinical /Administrative Primary Location : MI-Detroit : Hospital /Facility : DMC ... Regulatory Manager Full Time Days - 2506002316 Description : DMC Sinai-Grace Hospital is DMC's largest hospital , offering a comprehensive heart center,… more